EU regulators approve Novartis' breast cancer combo

European regulators have approved Novartis' Piqray (alpelisib) in combination with fulvestrant for the treatment of a certain type of breast cancer.

The decision allows the drug's use to treat postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy.

Piqray is the first and only treatment specifically approved for people with advanced breast cancer whose tumours harbor a PIK3CA mutation, which stimulates tumour growth and is associated with poor response to therapy.

“Piqray is an important new therapy for HR+/HER2- advanced breast cancer patients whose tumours have a PIK3CA mutation, and we look forward to making it available in countries across Europe,” said Kees Roks, head Region Europe, Novartis Oncology.

“Knowledge of PIK3CA status can better equip doctors as they develop a personalized upfront treatment plan for patients. Piqray offers new hope for advanced breast cancer patients with a PIK3CA mutation, who typically face a worse overall prognosis.”

Sangamo deal

Meanwhile, Novartis has linked with Sangamo to develop genomic medicines for autism and other neurodevelopmental disorders.

The collaboration will leverage Sangamo’s propriety genome regulation technology, zinc finger protein transcription factors (ZFP-TFs), Sangamo’s ZFP-TF genome regulation technology, which functions at the DNA level to selectively repress or activate the expression of specific genes to achieve a desired therapeutic effect.

Under the terms of the deal, over a three-year collaboration period, Novartis has exclusive rights to ZFP-TFs targeted to three undisclosed genes which are associated with neurodevelopmental disorders, and has the option to license the adeno-associated viruses (AAVs) which deliver ZFP-TFs.

Sangamo is responsible for certain research and associated manufacturing activities, all of which will be funded by Novartis, and Novartis assumes responsibility for additional research activities, investigational new drug-enabling studies, clinical development, related regulatory interactions, manufacturing and global commercialisation.

The Swiss drug giant will pay Sangamo a $75 million upfront license fee, and up to $720 million in other development and commercial milestone payments, including up to $420 million in development milestones and up to $300 million in commercial milestones.

Sangamo also stands to receive eligible to receive from Novartis tiered high single-digit to sub-teen double-digit royalties on potential net commercial sales of products arising from the collaboration.